Konakion MM 2 mg / 0.2 ml Paediatric

/ Tzamal

Prophylaxis
For all healthy neonates of 36 weeks gestation and older: 1 mg administered by intramuscular injection at birth or soon after birth or 2 mg orally at birth or soon after birth; the oral dose should be followed by a further dose of 2 mg at four to seven days of age. A further 2 mg oral dose should be given 1 month after birth. In exclusively formula-fed infants the third oral dose can be omitted.
A single 1 mg (0.1 ml) dose intramuscularly is recommended in children who are not assured of receiving a second oral dose or, in the case of breastfed children, who are not assured of receiving a third oral dose.
Preterm neonates of less than 36 weeks gestation, weighing 2.5 kg or greater, and term neonates at special risk (e.g. prematurity, birth asphyxia, obstructive jaundice, inability to swallow, maternal use of anticoagulants or antiepileptics): 1 mg intramuscularly or intravenously at birth or soon after birth. The amount and frequency of further doses should be based on coagulation status.
Preterm neonates of less than 36 weeks gestation, weighing less than 2.5 kg: 0.4 mg/kg (equivalent to 0.04 ml/kg) intramuscularly or intravenously at birth or soon after birth. This parenteral dose should not be exceeded. The amount and frequency of further doses should be based on coagulation status.
For dose calculation based on body weight for healthy and preterm neonates, please refer to Table 1 at the attached doctor’s leaflet.
There is evidence that oral prophylaxis is insufficient in patients with underlying cholestatic liver disease and malabsorption. Therefore oral vitamin K administration is not recommended in this category of patients.
Therapy
Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical
picture and coagulation status. In certain circumstances, treatment with Konakion MM paediatric
may need to be accompanied by more direct forms of effective hemorrhage control, such as
transfusion of whole blood or coagulation factors, to compensate for severe blood loss and the
delayed response to vitamin K1.
Administration
Oral use:
With the dispenser included in the package:
– after breaking the ampoule, place the dispenser vertically into the ampoule;
– withdraw the solution from the ampoule into the dispenser until the solution reaches the marking of the dispenser (= 2 mg vitamin K1);
– administer the contents of the dispenser directly into the newborn’s mouth
If no dispenser is available an alternative method of oral administration is the use of a syringe as follows:
– the required volume should be withdrawn from the ampoule with a syringe and needle;
– after removal of the needle the content of the syringe should be administered directly from the syringe into the newborn’s mouth.
Parenteral use: Konakion MM paediatric should not be diluted or mixed with other parenteral medications. It may however be injected into the lower part of an infusion set.

Prophylaxis and treatment of hemorrhagic disease of the newborn.

The use of Konakion MM paediatric is contraindicated in cases of known hypersensitivity to any of the ingredients.

Parenteral administration may be associated with an increased risk of kernicterus in premature infants weighing less than 2.5 kg.
At the time of use, the mixed-micelle ampoule solution must be clear in appearance.

In rare cases, anaphylactoid reactions have been reported after parenteral use of Konakion MM paediatric. Local irritation may occur at the injection site.

Vitamin K1 antagonizes the effect of coumarin-type anticoagulants.

There is no known clinical syndrome attributable to hypervitaminosis of vitamin K1.
The following adverse events have been reported concerning overdose with use of Konakion in
neonates and infants: jaundice, hyperbilirubinemia, increased GOT and GGT, abdominal pain,
constipation, soft stools, malaise, agitation and cutaneous eruption. The causality of those cannot
be established. The majority of these adverse events were considered non-serious and resolved
without any treatment.
Treatment of suspected overdose should be aimed at alleviating symptoms.